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临床试验/NCT03542253
NCT03542253Unknown不适用

Combined Diagnosis of CT and Exosome in Early Lung Cancer

Second Affiliated Hospital of Soochow University0 个研究点目标入组 80 人开始时间: 2018年5月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
主要终点
exosome in cancer tissue and para cancerous tissue

研究概览

简要总结

This experiment has now collected 50 cases, all through CT chest scans and blood exosome detection. Twenty-two patients underwent surgical treatment and 14 tissue specimens were examined for cancer and paracancerous tissue exosomesWe found that exosomal micor-A was highly expressed in early stage lung cancer tissues and was significantly higher than paracancerous tissues. The micor-A in the adjacent tissues was significantly higher than that in peripheral blood exosomes

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • At least 18 years of age, male or female;
  • No patients with acute disease;
  • Chest or LDCT examination for the first time found 5-30mm pulmonary nodule patients, and ruled out disseminated tuberculosis;
  • Past pulmonary nodes Festival failed to diagnose.
  • Have not received a history of surgical treatment of the lungs;
  • Patients who have not received targeted drugs, biological treatments, immunosuppressive agents, and modulators;
  • No organ transplants;
  • Signed informed consent before undergoing clinical studies Consent and adherence to the research protocol.

排除标准

  • Pulmonary nodules have been treated surgically (considering that surgery has been performed to interfere with the study);
  • History of organ transplants such as lung transplantation (consider the use of allogeneic genes and immunosuppressive agents);
  • Pregnancy or lactation (consider Failure to perform regular CT follow-up and fetal component effects.
  • Known HIV-positive or only AIDS-related diseases (taking into account interference with the use of immune drugs);
  • Being targeted drugs, immunosuppressive agents, immunomodulators, biotherapies Patients;
  • Active pulmonary tuberculosis (consider infectious and referral missing factors);
  • RNA-like viral infections: such as SARS, HIV, hepatitis virus (except for hepatitis B, the other four are all RNA viruses), influenza virus, Bird flu virus, H5N1, Ebola, measles, etc.
  • Various blood system diseases such as leukemia, lymphoma, aplastic anemia, myelodysplastic syndrome, anemia, hemolysis, hemophilia, DIC, etc.
  • Recent history of blood transfusion (within 3~6 years) and potential for blood transfusion;
  • Patients with neurological disorders and mental disorders unable to cooperate;
  • Emergency treatment for acute and severe diseases;
  • No Willing to sign a written informed consent and follow the study protocol before they are willing to conduct clinical research;
  • The presence of the patient may interfere with any psychological, family, social or geography conditions that obey the requirements of the research protocol or the follow-up procedure. Discuss these conditions with the patient before entering the study.

结局指标

主要结局

exosome in cancer tissue and para cancerous tissue

时间窗: one year

exosomal micor-A was highly expressed in early stage lung cancer tissues

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital of Soochow University
申办方类型
Other
责任方
Principal Investigator
主要研究者

gongjianping

Combined diagnosis of CT and exosome in early lung cancer

Second Affiliated Hospital of Soochow University

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